Patent Grant
11918733
This application claims the benefit of European Patent Application No. 18196941.1, filed Sep. 26, 2018, the contents of which are incorporated herein by reference as if fully rewritten herein.
The invention relates to a medical instrument for the application of an aerosol, as well as to a generation device for an aerosol.
Publications WO 2011/029572 A1, as well as WO 2011/029 573 A1 have disclosed medical instruments that comprise a head on the distal end of the instrument, in which a liquid, in particular a saline solution, and a gas, for example CO2, are combined for dispensing a mixture (aerosol) of liquid droplets that are finely divided in the gas with the instrument.
Publication EP 0 740 926 A2 describes a device comprising an aerosol jet formation component.
Medical instruments, in particular their heads on the distal end of the medical instruments, or applicators, frequently are intended for single use only because they need to be clean and sterile.
It is the object of the present invention to state an improved concept for an instrument for dispensing of an aerosol.
This object is achieved with a medical instrument, as well as with a generation device for an aerosol as described herein.
In one aspect of the invention, a medical instrument is disclosed. The medical instrument according to the invention has an aerosol outlet for dispensing an aerosol by means of the medical instrument. By means of an aerosol line, particularly preferably an aerosol hose line (hereinafter also referred to as hose line), the instrument is fluidically connected to a generation device, which generation device is adapted to generate an aerosol, and to supply the aerosol line with an aerosol for dispensing the aerosol by means of the medical instrument. The generation device is adapted to generate the aerosol by vaporizing a liquid by means of a gas stream.
Embodiments of the medical instrument according to the invention may be, for example, instruments for open surgery or endoscopic, in particular laparoscopic, surgery.
Considering embodiments, the instrument has a handling section, which handling section has an aerosol outlet, the handling section being fluidically connected to the generation device by means of the aerosol line, for example an aerosol hose line.
For example, the handling section may be formed by an applicator or hand grip part. The handling section is adapted for guiding, controlling the medical instrument during the procedure performed with the medical instrument, and/or, for example, for orienting the aerosol outlet for the desired dispensing direction of the aerosol.
For example, the medical instrument may be a probe for dispensing an aerosol, which probe may be adapted to be arranged in the working channel of an endoscope, so that the distal end of the probe projects from the working channel on the distal end of the endoscope. The outlet may be arranged on the distal end of the probe.
The medical instrument is preferably releasably connected to the generation device in order to uncouple the medical instrument, following use, from the generation device for the aerosol in order to connect, for example, an unused medical instrument to the generation device.
The medical instrument has been simplified in so far that no separate gas and fluid lines are required for conveying gas and liquid independently of each other up to an aerosol generation unit in the instrument, for example in the handling section of the instrument. A preferably flexible aerosol line from the generation device to the instrument—in embodiments up to the handling section—is sufficient. Of course, the medical instrument may comprise additional lines, also gas or fluid lines and/or electrical lines, which may lead to the instrument—in the embodiments to a handling section—which, however preferably are not used for aerosol generation in the medical instrument, e.g., in a handling section of the medical instrument.
In contrast with an instrument with two dedicated lines to a mixing unit for the generation of the aerosol in the instrument, e.g., in or on the handling section of the instrument, it is possible to reduce development and manufacturing costs when a generation device for generating aerosol in the instrument, e.g., in or on a handling section of the instrument, is absent. Development and manufacturing costs should be particularly low for single-use products. This makes the medical instrument particularly cost-effective regarding development and manufacture. The medical instrument may be a single-use instrument.
Preferably, it is possible with the aerosol line to implement large distances between the generation device for the aerosol and the instrument, in embodiments between the generation device for the aerosol and the handling section, or between the generation device and the aerosol outlet. Preferably, the length of the aerosol line between the generation device and the aerosol outlet or the instrument is at least 1 meter, particularly preferably, at least 2 meters.
During use of the instrument, the generation device for the aerosol is preferably supported by the base, for example via a carrying device. The generation device may be carried, for example, by a carrying device which is supported by the base. Referring to such embodiments, the user of the instrument need not himself carry the weight of the generation device during the medical application of the instrument. For example, the generation device may be arranged on a device which provides an electrical HF-output to be applied to an electrode, which electrode—in the embodiments of the inventive instrument—may be arranged in or on the instrument, for example, in or on a handling section. The device may be supported by the base, for example via a carrying device.
The instrument or the handling section, if any, can preferably be moved relative to the generation device. The generation device can be uncoupled from the instrument or handling section, if any, in such a manner that the generation device is not necessarily moved along due to the movement of the instrument during the medical application. Preferably, the generation instrument is arranged on a proximal end of a device which comprises the instrument according to the invention. Alternatively or additionally, the handling section is arranged on the distal end of the device which comprises the instrument according to the invention.
A device with the instrument is particularly cost-effective, as well as particularly quietly and simply to control, when the liquid is conveyed to the generation device without an electrically operated pump. An active conveying unit for the liquid such as, e.g., a syringe pump or a roller pump, can be omitted when a passive transport or admixing of the liquid by pushing the liquid to the mixing unit is accomplished by pressure above atmospheric pressure and/or by suction based on the Venturi pump or jet pump principle.
In another aspect of the invention a generation device is stated, with which an aerosol can be generated. For example, the generation device may be used in a device with the inventive instrument, which inventive instrument is described herein. However, the generation device can also be used independently of the embodiments of the inventive instrument described herein. The generation device according to the invention can be used for loading an instrument with aerosol, for example for open surgery or endoscopic, in particular laparoscopic, surgery, in order to be able to dispense aerosol by means of the instrument.
The generation device comprises a mixing unit in order to mix liquid and gas with each other to produce an aerosol. The mixing unit is connected to the liquid container for supplying the mixing unit with liquid. The generation device is adapted to use the gas pressure of a gas (pressurized gas) subjected to a pressure above atmospheric pressure to pressurize the liquid in order to press the liquid out of the liquid container to the mixing unit. In doing so, the gas can directly press on the liquid surface. Alternatively, the gas may press on a container, for example a bag that contains the liquid. The gas may press against a piston or a membrane which, in turn, presses directly on the liquid or a liquid container, for example a bag.
Embodiments of the generation device according to the invention, in which a compressible liquid container, e.g., a bag that is closed up to a port for the connection to the mixing unit, is arranged in a pressurized container, have the advantage that it can be ensured that the liquid supply is independent of, for example, the orientation of the liquid container, for example the bag, or the pressurized container that contains the liquid container.
Preferably, the liquid supply is independent of the position of the liquid container. This is preferably accomplished in that there is always a minimum liquid pressure acting on the connection of the mixing unit for supplying liquid, independent of the orientation and position of the liquid container. This can be accomplished by applying pressure to the liquid.
The device is particularly simple when the generation device is connected to a stationary or mobile pressurized gas storage such as, for example, a gas bottle, or a stationary pressurized gas network, as the source for the pressurized gas. For example, CO2 may be used as gas. Preferably, the source is adapted to provide gas with a pressure of a few Bar.
When the gas to be mixed with liquid to produce an aerosol and the gas that is determined to press on the liquid originate from the same gas source, it is not necessary to provide two independent gas sources (e.g., two gas bottles). Rather, one gas source (e.g., one gas bottle) is sufficient, said source delivering gas for supplying the mixing unit, as well as for charging the liquid in the liquid container with pressure.
In the embodiments, pressure from the outside is applied to a liquid container containing the liquid in order to convey the liquid to the mixing unit.
Preferably, the liquid container is adapted and intended to be compressed in order to be able to compress the liquid container due to the pressure, in order to thus press liquid out of the liquid container to the mixing unit.
For example, the liquid container may be a bag. Preferably, a standard bag is used as is available in hospitals where the generation device is used. If a standard bag is used, the filling of a special fluid container for the device may be omitted. For example, the fluid may be a sterile isotonic saline solution. For example, the bag may be an infusion bag as is commonly used in hospitals.
In the embodiments, the liquid container is arranged in a pressurized container, in which case pressure is applied to the pressurized container in order to press the liquid out of the liquid container to the mixing unit. In the pressurized container, the gas pressure of the gas can directly act on the liquid container. This makes the generation device particularly simple. Alternatively, the pressure may act, for example, on a membrane or a piston, which membrane or which piston acts on the liquid container. Or the liquid is arranged in a cylinder in one of two working chambers, which are separated from each other by a piston, in which case the other working chamber is pressurized with pressurized gas in order to press the liquid out of the working chamber by means of the piston.
In embodiments, the pressurized container itself may be the liquid container, in that the wall of the pressurized container prevents the liquid from flowing out. Pressure can be applied by the pressurized gas above the fluid level in the chamber, said gas potentially having contact with the liquid surface in order to press the liquid out of the pressurized container.
Preferably, the mixing unit works according to the Venturi pump or the jet pump principle for mixing the liquid with the gas. The mixing unit preferably comprises a channel with a constriction, in which case the channel is connected to the pressure source upstream of the constriction, and in which case the fluid container is connected to the channel downstream of the constriction and/or at the constriction. If the channel is supplied with pressurized gas upstream of the constriction, the gas flow is accelerated and the static pressure in the constriction and downstream of the constriction is decreased due to the constriction. If a fluid line is connected from the liquid container to the region with reduced static pressure to the mixing unit, the reduced static pressure promotes the loading of the channel with liquid that is drawn along by the accelerated gas in order to produce the aerosol.
A particularly simple design is attained if the channel is connected upstream of the constriction to the same pressure source of pressurized gas, which pressure source is also adapted to apply pressure to the liquid in the liquid container in order to press said liquid into the mixing unit. In particular, the channel can be connected to a pressurized gas storage (stationary or mobile) such as, for example, a gas bottle or a pressurized gas network, for example a pressurized gas network of a building, in particular a hospital building, in which case the pressurized gas storage or the pressurized gas network also is adapted to apply pressure to the fluid in the fluid container. For example, between the constriction of the channel and the pressure source, there may be provided a line branching point with two branch lines, in which case one branch line leads to the constriction and the other leads to the pressurized container. If the generation device comprises a line connected to the pressure source, said line branching between the constriction and the pressure source, in order to supply—from the line—the constriction with gas as well as provide the gas to apply pressure to the liquid, then such a branching point is preferably arranged in the mixing unit. The gas stream from the pressure source is divided into two partial streams, of which a first partial stream flows to the mixing unit and a second partial stream flows to the liquid container in order to apply pressure to the liquid by means of the second partial stream.
In a device, an instrument for dispensing aerosol via an aerosol line is connected to the generation device as described herein, in which case the proximal end of the aerosol line and the generation device remains outside the body of the patient while the instrument is being used. The proximal end of the aerosol line is connected to the generation device described herein in order to supply the instrument by means of the generation device with aerosol via the aerosol line.
Additional features of the instrument according to the invention and the generation device according to the invention, as well as the device according to the invention, can be inferred from the dependent claims, as well as the description and the schematic figures hereinafter. They show in
The generation device 12 preferably comprises a mixing unit 25 that contains a Venturi nozzle.
The mixing unit 25 is connected to a source 36 for pressurized gas, in particular CO2, by means of a first pressurized gas line 35, in order to load the mixing unit 25 with pressurized gas from the source 36. As shown by
Embodiments of the device 11 according to the invention comprise such a container 45 (pressurized container) that can be loaded with pressurized gas. By means of the gas pressure, a fluid, in particular a saline solution contained in the pressurized container 45, is to be pressed out of the container 45 to the mixing unit 25.
In the exemplary embodiments that represent alternatives to the exemplary embodiments according to
Between the liquid container 49 and the orifice 31 in the channel 26 on the port 30 of the mixing unit 25 for the fluid, there may be arranged a throttle device 65 to reduce the pressure in the fluid line 55 between the liquid container and the orifice 31 in the channel 26. In doing so, the flow rate of the liquid can be adjusted. The greater the pressure drop generated on the throttle device 65, the lower is the flow rate of liquid. In doing so, the mixing ratio of gas and liquid can be adjusted. In the channel section 40 of the mixing unit 25 upstream of the constriction, the static pressure of the gas flow is greater than in the constriction, toward which the flow is accelerated in a flowing manner, and, consequently, the static pressure decreases.
The generation device 12 and/or the source 36 preferably are supported by the base—for example, via one or more carrying devices.
The device 11 works as follows. The flow directions in the lines and channels are identified in the Figures by arrows P next to or in the lines and channels:
The channel 26 of the mixing unit 25 is loaded with gas, for example CO2, by means of the gas bottle 36, with a pressure of a few Bar, for example greater than or equal to 2 Bar, for example approximately 7 Bar. When, on the handling section 15, the passage through the line that forms the channel 17 in the handling section 25 is cleared, the gas flows through the channel 17 and the second pressurized gas line 44 into the pressurized container 45 and presses the liquid there out of the pressurized container 45 to the mixing unit 25. This may happen, in that the gas pressure acts directly on the liquid bag 49 compressing said bag (according to
The thusly produced aerosol enters from the aerosol outlet of the mixing unit 25 into the aerosol line 20 and is conveyed through the channel 17 in the handling section 15 to the aerosol outlet 16 of the instrument 10 on the handling section 15 in order to be dispensed there. In the nozzle, upstream of the aerosol outlet 16 on the handling section 15—which is formed by the constriction 18—the aerosol flow is accelerated by means of the nozzle.
If, as in the described embodiments, the mixture of aerosol takes place on the proximal end 21 of the instrument 10, the continued transport of the gas-water mixture to the distal end of the handling section 15 (aerosol applicator) may occur only through an aerosol line 20, so that another line will be unnecessary. For example, the mixing unit 25 may be arranged in an apparatus, to which the instrument 10 is connected. The apparatus-side mixing unit 25, in which the gas and the fluid are joined, may have the shape of a Y, for example.
In doing so, the transport of the liquid stream may preferably take place by means of a passive transport unit, i.e., without an electrically operated pump. Preferably, there is no electrically operated pump between the liquid container 49 and the location 31 at which the fluid enters the channel 26 in the mixing unit 25, which pump would be adapted and intended to transport liquid in the channel 26 of the mixing unit 25. To do so, according to embodiments of the invention, the pressure of a pressurized gas storage 36 such as, for example, a gas bottle, is used to supply the mixing unit 25 which, additionally preferably, may form a jet pump, and, on the other hand, press the fluid out of the fluid container 49 to the mixing unit 25. Compared to a device which comprises an active transport unit for the liquid such as, e.g., a syringe pump or a roller pump, the device 11 according to the invention provides—in the embodiments in which such a pump between the liquid container 49 and the mixing unit 45 is omitted—the advantage that the cost for an active transport unit in the device can be saved. As a result of this, the device 11 according to the invention is relatively inexpensive to manufacture and maintain and thus comparatively more favorable. Furthermore, the mass flow of fluid is a function of the pressure applied in the first pressurized gas line 35. Thus, the quantity of aspirated liquid is also a function of the pressure in the first pressurized gas line 35. Therefore, the suggested transport provides self-adjustment. The stronger the suction of the jet pump is on the fluid line 55, said jet pump being formed by the mixing unit 25 having the constriction 27, the stronger the liquid is pressed out of the fluid container 49 into the fluid line 55 due to the application of pressure by the pressurized container 45.
Disclosed is a medical instrument 10 with an aerosol outlet 16, which is fluidically connected—via an aerosol line 20—to a generation device 12. The generation device 12 is adapted to generate aerosol for dispensing by means of the medical instrument 10. In addition, a generation device 12 is stated, which, in embodiments of the generation device 12, for example can be used in a device 11 with the instrument 10 according to the invention. The generation device 12 comprises a mixing unit 25 for mixing a liquid and a gas together, which mixing unit 25 is connected to a liquid container 49 for supplying the mixing unit 25 with a liquid, in which case the generation device 12 is adapted to utilize the gas pressure of a gas under pressure subjecting the liquid to a pressure in order to press the liquid out of the liquid container 49 to the mixing unit 25.
| Number | Date | Country | Kind |
|---|---|---|---|
| 18196941 | Sep 2018 | EP | regional |
| Number | Name | Date | Kind |
|---|---|---|---|
| 2153240 | Dailey | Apr 1939 | A |
| 2177032 | Baumgardner | Oct 1939 | A |
| 2847249 | Evans | Aug 1958 | A |
| 3198438 | Hultgren | Aug 1965 | A |
| 3270920 | Nessler | Sep 1966 | A |
| 3507278 | Werding | Apr 1970 | A |
| 3580249 | Takaoka | May 1971 | A |
| 3809080 | Deaton | May 1974 | A |
| 3838794 | Cogley | Oct 1974 | A |
| 3949753 | Dockhorn | Apr 1976 | A |
| 4048994 | Lo | Sep 1977 | A |
| 4162030 | Capra | Jul 1979 | A |
| 4174071 | Lau | Nov 1979 | A |
| 4215476 | Armstrong | Aug 1980 | A |
| 4376376 | Gregory | Mar 1983 | A |
| 4406406 | Knapp | Sep 1983 | A |
| 4551136 | Mandl | Nov 1985 | A |
| 4913698 | Ito | Apr 1990 | A |
| 4974634 | Agulia | Dec 1990 | A |
| 5074839 | Choksi | Dec 1991 | A |
| 5094269 | Agulia | Mar 1992 | A |
| 5399159 | Chin | Mar 1995 | A |
| 5497912 | Hoback | Mar 1996 | A |
| 5695653 | Gsell | Dec 1997 | A |
| 5720728 | Ford | Feb 1998 | A |
| 5730731 | Mollenauer | Mar 1998 | A |
| 5797520 | Donahue | Aug 1998 | A |
| 5951461 | Nyo | Sep 1999 | A |
| 6083189 | Gonon | Jul 2000 | A |
| 6096007 | Haan | Aug 2000 | A |
| 8945605 | Boucher et al. | Feb 2015 | B2 |
| 20030155011 | Gilmore | Aug 2003 | A1 |
| 20030181917 | Gertner | Sep 2003 | A1 |
| 20040154617 | Enk | Aug 2004 | A1 |
| 20040231668 | Kates | Nov 2004 | A1 |
| 20040232171 | Bobst | Nov 2004 | A1 |
| 20060175433 | Escoto, Jr. | Aug 2006 | A1 |
| 20070164133 | Lin | Jul 2007 | A1 |
| 20070181599 | Kosmyna | Aug 2007 | A1 |
| 20080110458 | Srinivasan et al. | May 2008 | A1 |
| 20080125742 | Podhajsky | May 2008 | A1 |
| 20090050137 | Wissink | Feb 2009 | A1 |
| 20090326621 | El-Galley | Dec 2009 | A1 |
| 20100059605 | Plantz | Mar 2010 | A1 |
| 20110137281 | Tang | Jun 2011 | A1 |
| 20110230820 | Lillis | Sep 2011 | A1 |
| 20120048264 | Finlay | Mar 2012 | A1 |
| 20120167878 | Belson | Jul 2012 | A1 |
| 20120172789 | Fischer et al. | Jul 2012 | A1 |
| 20120172874 | Fischer et al. | Jul 2012 | A1 |
| 20130079733 | Burt | Mar 2013 | A1 |
| 20130200537 | Ken | Aug 2013 | A1 |
| 20140109899 | Boucher et al. | Apr 2014 | A1 |
| 20140114261 | Geppert | Apr 2014 | A1 |
| 20150028131 | Joseph | Jan 2015 | A1 |
| 20150040902 | Blum | Feb 2015 | A1 |
| 20150209545 | Houston | Jul 2015 | A1 |
| 20160213864 | Eilat | Jul 2016 | A1 |
| Number | Date | Country |
|---|---|---|
| 104225705 | Dec 2014 | CN |
| 0740926 | Nov 1996 | EP |
| 2338587 | Jun 2011 | EP |
| 3244820 | Jun 2020 | EP |
| 2488992 | Sep 2012 | GB |
| H08336573 | Dec 1996 | JP |
| 2005-262037 | Sep 2005 | JP |
| 2007508930 | Apr 2007 | JP |
| 2008-515606 | May 2008 | JP |
| 2012-223688 | Nov 2012 | JP |
| 2013-150987 | Aug 2013 | JP |
| 2014-100563 | Jun 2014 | JP |
| 20020022222 | Mar 2002 | KR |
| 200400064 | Jan 2004 | TW |
| 2011029572 | Mar 2011 | WO |
| 2011029573 | Mar 2011 | WO |
| 2016115031 | Jul 2016 | WO |
| Entry |
|---|
| Extended European Search Report dated Mar. 26, 2019, in corresponding European Patent Application No. 18196941.1 (9 pages). |
| Office Action dated Jun. 15, 2022, in corresponding Russian Application No. 2019129553 (24 pages). |
| Office Action and Search Report dated Jul. 20, 2022 in corresponding Chinese Application No. 2019109170227, 24 pages. |
| China National Intellectual Property Administration; 2nd Office Action and Search Report in corresponding Chinese Application No. 2019109170227, dated Mar. 17, 2023; 10 pages. |
| Japan Patent Office; Notice of Reasons for Refusal in corresponding Japanese Patent Application No. 2019-173782, dated Jun. 9, 2023; 23 pages. |
| China National Intellectual Property Administration; Decision to Grant Patent in corresponding Chinese Patent Application No. 201910917022.7, dated Jul. 10, 2023; 19 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20200093999 A1 | Mar 2020 | US |
